Tapinarof Cream 1% Approved by FDA to Treat Atopic Dermatitis in Adults, Children 2 Years and Older
Vtama from Organon was previously approved in May 2022 to treat plaque psoriasis in adults.
The FDA approved tapinarof (Vtama) cream 1% for the treatment of atopic dermatitis in adults and pediatric patients aged 2 years and older, pharmaceutical company Organon announced in a release.1 The therapy was initially approved in May 2022 for the treatment of plaque psoriasis in adult patients.
Tapinarof Cream 1% Approved by FDA to Treat Atopic Dermatitis in Adults, Children 2 Years and Older / Tada Images - stock.adobe.com
Tapinarof cream 1% is a novel, aryl hydrocarbon receptor agonist that is cosmetically elegant and steroid-free. The therapy is intended as a once-daily treatment for both acute and long-term management of atopic dermatitis. Upon its initial approval in May 2022, tapinarof cream was the first non-steroidal topical novel chemical entity approved for plaque psoriasis in the United States in over 25 years.
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“Vtama cream approval in atopic dermatitis is important because it can be prescribed for children as young as 2 years old,” Adelaide A Hebert, MD, lead investigator for the ADORING program, said in a release.1 “Vtama cream has the potential to bring much needed relief to a significant number of children suffering from this disease. Moreover, because the prevalence of itch makes this condition extremely burdensome to patients and their families, the itch data from the ADORING program demonstrates reduction of one of the condition’s most prevalent symptoms with use of Vtama cream.”
The approval of tapinarof cream 1% for the additional atopic dermatitis indication was based on data from the ADORING clinical program, which included 3 studies: ADORING 1 (NCT05014568), ADORING 2 (NCT05032859) and ADORING 3 (NCT05142774). In the studies, tapinarof cream 1% showed a statistically significant difference to vehicle in the proportion of patients who achieved clear or almost clear on the Validated Investigator Global Assessment for Atopic Dermatitis.
ADORING 3, a long-term, phase 3 extension study that enrolled patients from ADORING 1 and 2, evaluated the safety and efficacy of tapinarof cream 1% in adults and pediatrics patients aged 2 years and older with atopic dermatitis. The study cohort included 728 patients, of which 83% were pediatric, who were followed for up to 48 weeks. The primary study outcomes included number of patients with adverse events, frequency of adverse events, and number of patients with clinically meaningful changes from baseline.
The study found that 51.9% of patients entered with or achieved complete disease clearance at least once during the study period, and 81.6% entered with or achieved clear or almost clear skin at least once. After discontinuing treatment, the average duration of the first treatment-free interval was 79.8 consecutive days. There was no evidence of loss of response in patients receiving either continuous or intermittent therapy during the study.2
Tapinarof cream was well tolerated, with most adverse events being mild to moderate. The therapy was also well tolerated when applied to sensitive areas, such as the face and neck. The most common adverse events were folliculitis, nasopharyngitis, and upper respiratory tract infection.
“With the FDA’s approval of Vtama cream in atopic dermatitis for adults and children as young as 2 years old, there is now a therapy that offers the potential for powerful skin clearance with no label warnings or precautions, contraindications, and no restrictions on duration of use or percentage of body surface area affected,” Kevin Ali, CEO of Organon, said in a release.1 “Introducing this new first-in-class therapy for atopic dermatitis patients reaffirms Organon’s commitment to addressing areas of high unmet need.”
READ MORE: Dermatology Resource Center
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